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Jenacell GmbH is seeking a Quality Assurance Analyst for their Lafayette, IN location. The role involves ensuring compliance with GMP and ISO standards, overseeing production quality events, and collaborating with operations to maintain quality processes.
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Job Summary
Provide or approve the initial assessments for all quality events and collaborate with Operations to review and approve minor deviations and change controls.
Disposition all GMP API and final intermediate batches produced in the production area and support auto-disposition of non-final intermediates.
This position is responsible to ensure that daily manufacturing operations remain compliant with cGMP and ISO 9001 requirements.
Matching Summary
Match Score: 75
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Jenacell GmbH is seeking a Quality Assurance Analyst for their Lafayette, IN location. The role involves ensuring compliance with GMP and ISO standards, overseeing production quality events, and collaborating with operations to maintain quality processes.
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Skills & Requirements
Must-have
production issues and compliance
quality events assessment
deviations and change controls
GMP API batch disposition
cGMP and ISO 9001 requirements
Nice-to-have
continuous improvement initiatives
customer audits and inspections
hybrid and flexible working
Key Requirements
BS in chemistry, engineering, science, or equivalent experience
3-5 years industrial experience in a GMP environment
Demonstrated application of GMPs
Good communication skills (written and verbal)
Computer skills; Microsoft Office programs required